Kornimate/medical-research-clean huggingface dataset:
a study to evaluate id-085 in people with mild, moderate, and severe kidney disease

Conditions: Renal Impairment

Summary: the primary objective of this study is to evaluate the pharmacokinetics (pk), tolerabilty and safety of a single dose of id-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects


Eligibility criteria:
inclusion criteria: all subjects: * signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * male and female subjects aged between 18 and 79 years (inclusive) at screening. * body mass index (bmi) of 18.0 to 34.0 kg/m2 (inclusive) at screening. body weight of at least 50 kg. * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day-1. they must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) a highly effective method of contraception with a failure rate of \< 1% per year and must use condoms, diaphragm or cervical cap with spermicide, or be sexually abstinent. hormonal contraceptive must be initiated at least 1 month before study treatment administration. renal function impairment subjects: • at screening and on day -1, the stage of renal function impairment will be defined by creatinine clearance (clcr) by the cockcroft-gault (c-g) equation: * mild renal function impairment: clcr 60-89 ml/min (group a). * moderate renal function impairment: clcr 30-59 ml/min (group b). * severe renal function impairment: clcr \<30 ml/min (group c). the stage of renal impairment will need to be confirmed at day -1 and the clcr values on day -1 will need to remain within ± 25% of the screening value. healthy subjects: • normal renal function confirmed by a clcr ≥ 90 ml/min. normal renal function will need to be confirmed at day -1 and the clcr value on day -1 will need to remain within ± 25% of the screening value. exclusion criteria: all subjects: * pregnant or lactating women. * known hypersensitivity to id-085 or treatments of the same class, or any of its excipients. * known hypersensitivity or allergy to natural rubber latex. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. renal function impairment subjects: * subjects on dialysis. * hemoglobin concentration \< 9 g/dl. * serum potassium concentration \> 6 mmol/l. * platelet count \< 100 × 10\^6/ml. * history of severe renal stenosis. * history of clinically relevant bleeding disorder. * gastrointestinal bleeding within 2 weeks prior to screening. * presence of unstable diabetes mellitus.
heartlight ablation in patients with paroxysmal atrial fibrillation (paf)

Conditions: Paroxysmal Atrial Fibrillation

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the cardiofocus endoscopic ablation system with adaptive contact (heartlight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

a randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Eligibility criteria:
inclusion criteria: * 18 to 75 years. * paroxysmal atrial fibrillation * failure of at least one aad * others exclusion criteria: * overall good health as established by multiple criteria

Keywords: atrial fibrillation af paf pvi ablation paroxysmal atrial fibrillation pulmonary vein isolation
analyses of malnutrition screening in internal medicine

Conditions: Malnutrition

Summary: the goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients. the main questions it aims to answer are: 1. how many patients are at risk of malnutrition at admission? 2. is there a link between an existing malnutrition risk and nutrition therapy that the patients receive? 3. is there a link between an existing malnutrition risk and clinical outcome (e.g. length of hospital stay, mortality, need for rehospitalization)? participants will be screened for malnutrition risk at admission using a validated questionnaire (nutritional risk screening 2002). all relevant data regarding hospital stay will be obtained from the clinical information system after discharge.

malnutrition is associated with adverse clinical outcome in hospitalized patients. therefore, systematic screening for malnutrition risk at admission is recommended by almost all medical expert societies to identify patients who will benefit from nutritional therapy. although clinical and economic benefit of systematic malnutrition screening have been shown in various settings and for different patient groups, such screening is still not mandatory in most countries. in part, establishment of malnutrition screening is hampered by discrepant findings on the prevalence of malnutrition risk and the lack of evidence on a local level. hence, in this observational study the investigators examine the results of systematic malnutrition screening in internal medicine patients admitted to a university hospital in northeast germany. in particular, the investigators aim to determine the prevalence of malnutrition risk at hospital admission, the association between malnutrition risk and nutrition therapy as well as clinical outcome in different disciplines of internal medicine. for this purpose, all patients undergo screening for malnutrition risk at admission using a validated instrument (nutritional risk screening 2002). all relevant data regarding the patients' hospital stay will be obtained from the clinical information system after discharge.

Eligibility criteria:
inclusion criteria: * hospital admission for gastrointestinal, endocrine, rheumatic, or nephrological condition * provision of informed consent exclusion criteria: * inability to provide consent * unfeasibility to perform malnutrition screening within 48h after admission

Keywords: malnutrition risk screening internal medicine nutritional risk screening 2002 gastroenterology nephrology endocrinology rheumatology
the effect of cinnamon on hba1c among adolescents with type i diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.

widespread achievement of glucose control remains an elusive goal for adolescents with type 1 diabetes. previous research has suggested that cinnamon may be effective at improving glucose control in type 2 diabetes. to date, no research has investigated the effect of cinnamon on type 1 diabetics. if the addition of a simple, natural, pill to a standard insulin regimen can significantly improve glucose control, the clinical implications would be substantial. comparison: using a prospective, double-blind, placebo-controlled design, 72 adolescent type i diabetics were treated with cinnamon (1 gram/day) or an equivalent appearing placebo for 90 days. hba1c, total daily insulin intake, and adverse events were recorded and compared between groups.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 1 diabetes for \> 18 months prior to enrollment, 2. age 13-18 years at the time of enrollment 3. presenting to the clinic for routine care, 4. no hospital admissions for medical or psychiatric reasons in the 12 months prior to enrollment, 5. accessible by phone, 6. not pregnant. exclusion criteria: (1) pregnant

Keywords: cinnamon type 1 diabetes adolescent hba1c
efficacy and safety of tenalisib (rp6530), in patients with locally advanced or metastatic breast cancer

Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Summary: phase ii, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.

the study will have two groups, group 1 with a treatment option of 800mg rp6530 bid and group 2 with a treatment option of 1200mg rp6530 bid, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.

Eligibility criteria:
inclusion criteria: 1. patients must be ≥18 years of age, at the time of signing informed consent. 2. female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy. 3. patients with at least one measurable lesion per recist version 1.1 at baseline that can be accurately assessed by ct scan or mri and is suitable for repeated assessment at follow up-visits. 4. ecog performance status 0 to 2. 5. life expectancy of at least 3 months. 6. adequate bone marrow, liver, and renal functions 7. female patients of childbearing potential should be willing to use a medically acceptable method of contraception exclusion criteria: 1. patients with her-2 positive breast cancer. 2. patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to c1d1, whichever is shorter. 3. patient who has not recovered from acute toxicities (defined as nci-ctcae grade \> 1) of previous therapy except treatment-related alopecia. 4. patients who have had disease progression within 8 weeks of platinum chemotherapy. 5. prior exposure to investigational or marketed pi3k inhibitors given for the treatment of breast cancer. 6. major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery. 7. patient with symptomatic uncontrolled brain metastasis. 8. hiv-positive patients who are on antiretroviral therapy or active hepatitis c or active hepatitis b virus infections. 9. ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication. 10. known history of severe liver injury as judged by the investigator. 11. history of severe cutaneous reactions in the past. 12. active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as crohn's disease or ulcerative colitis. 13. pregnancy or lactation. 14. patient with other active malignancies at the time of screening.

Keywords: rp6530 tenalisib
cognitive behavioral therapy for adherence in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Depression

Summary: despite the significant relationship between depression and diabetes, there are few published studies testing the effect of cognitive behavioral therapy in improving disease outcomes among diabetics in primary healthcare settings in egypt. the study aims at assessing the efficacy of cognitive behavioral therapy combined with diabetes education versus control receiving diabetes education alone in helping patients with type 2 diabetes and depressive symptoms to achieve glycemic control and compliance to treatment.

the psychological status of diabetic patients impacts their health behavior and clinical outcomes significantly. psychological interventions are important tools to amending health behavior in type 2 diabetes (t2d). cognitive behavioral therapy (cbt) has been an effective non-pharmacologic treatment for a wide variety of mental disorders such as depression, anxiety, post-traumatic stress disorder, eating disorders, and schizophrenia. the therapeutic approach promotes coping capabilities against difficult situations. it targets a change in negative patterns of cognition and associated behaviors and promotes emotional regulation. depression in diabetic patients is under-recognized. it is estimated that 44% of depressed patients are recognized by practitioners. such lack of recognition is attributed to poor diabetic outcomes. there is a growing body of research that explores the effectiveness of this psychological technique in managing chronic physical diseases. despite the success of cbt in managing psychiatric morbidities, research on its use in the treatment of diabetes is limited and with varying results. moreover, the majority of studies that have investigated the burden of depression in t2d have been carried out in high-income countries, but little is done in the middle east and north africa (mena) region especially egypt.

Eligibility criteria:
inclusion criteria: * patients meeting the american diabetes association (ada) criteria for t2d (glycated hemoglobin (hba1c) ≥6.5%, fasting glucose ≥126mg/dl) with diagnosis confirmed by the participants' medical clinicians. * participants aged more than 35 years; ambulatory; able to give informed consent; and able to obtain reliable information. * eligible patients will be screened for depressive symptoms using the beck depression inventory (bdi). they will be included if they score 11-30 based on bdi (mild mood disturbance to moderate depression). exclusion criteria: * participants will be excluded if they have type i diabetes and psychiatric disorders other than mood or personality disorders. depressed patients on treatment for depression will not be included. * suicidal patients and those diagnosed with major depressive disorder will be referred to a psychiatrist.

Keywords: type 2 diabetes depression treatment adherence cognitive behavioral therapy randomized controlled trial
pre and post treatment metabolomic analysis of leukemia: a translational clinical trial of the brown cancer center

Conditions: Leukemia

Summary: to characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy. to compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients.

to characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after c13-glucose administration at strategic time points of treatment. to detect and measure 13c-labeled metabolic markers which may be present in the serum and urine of leukemic patients. to characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after c13-glucose administration at strategic time points of treatment. to detect and measure 13c-labeled metabolic markers which may be present in the serum and urine of leukemic patients.

Eligibility criteria:
inclusion criteria for leukemia subjects: * each of the criteria in the following section must be met in order for a patient to be eligible for enrollment. * only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study. * all patients must have measurable quantities of leukemic blasts on peripheral blood detected with a cbc. * no history of diabetes for the experimental group or the control group. * patients with known hepatitis c or hiv (aids) are excluded. * patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. inclusion criteria forhealthy subjects: * subjects must have no known prior history of cancer or malignant blood disorders. -where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. this will be done by a phone call performed one month from sample to ask if new medical conditions have arisen. * subjects must have wbc, rbc, and platelet counts within normal range on cbc. * subjects with known hepatitis c or hiv (aids) are excluded. * no history of diabetes * at least 30 years of age * preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment * patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. exclusion criteria: * none listed in protocol
a study of skb264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab as first-line treatment for pd-l1 negative patients with locally advanced or metastatic non-squamous non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the study aims to evaluate the efficacy and safety of skb264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous nsclc with pd-l1 negative.

this is a randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of skb264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous nsclc with pd-l1 negative.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed non-squamous nsclc, and unsuitable for radical surgery and/or radical concurrent/sequential radiochemotherapy, locally advanced (stage iiib/iiic) or metastatic (stage iv) nsclc; 2. egfr-sensitive mutation negative \[no exon 19 deletion (19-del) or exon 21 point mutation (l858r mutation)\] and alk fusion gene negative, without known ros1 gene fusion, ntrk gene fusion, braf v600e mutation, etc. that have been approved for targeted therapy driving gene alterations; 3. no prior systemic anti-cancer therapy for locally advanced or metastatic nsclc; 4. participants whose tumours are pd-l1 tps ≥ 1%; 5. at least one measurable lesion per recist v1.1; 6. eastern cooperative oncology group (ecog) performance status of 0 to 1 with no worsening within 7 days prior to randomization; 7. a life expectancy of at least 12 weeks; 8. adequate organ and bone marrow function; exclusion criteria: 1. histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%; 2. previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy; 3. active second malignancy; 4. symptomatic or uncontrolled cardiovascular disease，serious thromboembolic； 5. history of noninfectious pneumonitis/interstitial lung disease (ild) that required steroids or has current pneumonitis/ild; 6. active infection requiring systemic therapy within 2 weeks of randomization; 7. active hepatitis b or hepatitis c virus infection; 8. human immunodeficiency virus (hiv) positive or history of acquired immunodeficiency syndrome (aids); known active syphilis infection; 9. major surgery within 4 weeks prior to randomization or expected major surgery during the study; 10. pregnant or lactating women;
observational study of biphasic insulin aspart 30 alone or in combination with oral hypoglycaemic agents in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in africa, asia and europe. the aim of this study is to investigate biphasic insulin aspart 30 (novomix® 30) alone or in combination with oral hypoglycaemic agent (oha) for type 2 diabetes management in routine clinical practice.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
energy and protein adequacy of oral intake after ventilator withdrawal among critically ill patients.

Conditions: Critical Illness; Nutritional Imbalance

Summary: the aim of this study is to evaluate the adequacy of exclusive oral intake, in terms of energy-protein amount, after extubation in critically ill patients who remained on invasive mechanical ventilation for at least 48 hours.

a prospective observational study. the adequacy of exclusive oral consumption will be assessed in a consecutive sample of critically ill patients after ventilator removal by visual intake scale in 0%, 25%, 50%, 75%, or 100% of principal meals, i.e., lunch and dinner, during seven days after recruitment. to characterize the study population, general characteristics of patients and their hospital outcomes will be collected: sociodemographic (age, sex, ethnicity, education) and admission clinical data (weight, height, simplified acute physiology score 3, nutritional risk screening, and subjective global assessment), energy and protein intake within 72 hours after initiation of invasive mechanical ventilation, the underlying disease that led to hospitalization, length of stay in the icu, length of invasive mechanical ventilation and hospital stay, the incidence of infections after icu discharge and in-hospital death.

Eligibility criteria:
inclusion criteria: * adult critically ill patients * mechanical ventilation for at least 48 hours and who migrate to exclusively oral feeding within seven days after extubation without receiving complementary parenteral or enteral nutrition. * admitted to the icu in hospital de clínicas de porto alegre from march 2022 to october 2022. exclusion criteria: * pregnancy * occurrence of major abdominal surgery during icu stay * tracheostomized patients * patients unable to start an oral diet after extubation. * patients previously included in the study. * patients seeking exclusive palliative care
trial of pde4 inhibition with roflumilast for the management of atopic dermatitis (integument-ii)

Conditions: Atopic Dermatitis Eczema

Summary: this study will assess the safety and efficacy of arq-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). this is a parallel group, double blind, vehicle-controlled study in which arq-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.


Eligibility criteria:
inclusion criteria: 1. participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. 2. males and females, ages 6 years and older at time of signing informed consent (screening). only subjects 18 years and older will be enrolled at sites located in the province of québec in canada. 3. diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the investigator. stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. 4. females of childbearing potential (focbp) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline/day 1. in addition, sexually active focbp must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. 5. in good health as judged by the investigator. 6. subjects considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: 1. subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator 2. has unstable ad or any consistent requirement for high potency topical steroids. 3. subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (leds) for 4 weeks prior to baseline/day 1 and during the study. 4. females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 5. previous treatment with arq-151. 6. subjects with a history of chronic alcohol or drug abuse within 6 months prior to screening. 7. parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation. 8. subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.